On the first anniversary of the approval of the first BCMA-targeted CAR-T therapy, IASO Biologics has been invested by Innovent Biologics, what will be the second half of commercialization?

Source of this article: Times Finance Author: Zhang Yuqi

On the occasion of the first anniversary of the approval of the CAR-T cell therapy Igneucel Injection (trade name: Fukesu), IASO Biologics and Innovent Biologics (01801. HK) has reached another cooperation on this product.

IASO Biologics disclosed on July 5 that the company will purchase the relevant rights and interests of Innovent Biologics under the original BCMA CAR-T cooperation agreement at the agreed price; At the same time, Innovent will take a stake in IASO Biotech at the same price, and will hold an 18% stake in IASO Biotech after the shareholding. IASO Biotech will obtain the rights and interests of commercialization rights and intellectual property licenses in the global market, and will be independently responsible for and make decisions on the development, production and sales of products. At the same time, Innovent became a strategic shareholder of IASO Biologics.

Regarding the cooperation with Innovent Biologics, IASO Biologics told Times Finance, "Our original intention of deciding to update the cooperation model is based on an in-depth analysis of the current market environment and future development trends. As a cutting-edge technology in the field of biomedicine, CAR-T cell therapy has great development potential and market demand. In order to better capitalize on this opportunity, we believe it is necessary to improve overall operational efficiency through closer collaboration and more effective integration of resources from both parties. ”

"With IASO Biotech being the sole responsible for the commercialization of Fukesu, it can more effectively promote the commercialization of Fukesu in the country, maximize the commercial value of Fukesu, and rapidly expand to the world. Based on the trust and recognition of our long-term cooperation, Innovent will continue to support IASO as a shareholder. We believe that the new partnership model will also allow us to be more agile in responding to market changes, respond quickly to the needs of patients and healthcare professionals, and improve our competitiveness in the market." Reindeer Biology further explained to Times Finance.

On June 30, 2023, the National Medical Products Administration (NMPA) approved the product for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed on at least 3 prior lines of therapy (at least one proteasome inhibitor and immunomodulator). This is the world's first commercially available fully human CAR-T product, the first self-developed and full-process CAR-T cell therapy in China, the first approved BCMA targeted CAR-T product in China, and the first approved cell therapy product for the treatment of multiple myeloma in China.

In March 2024, the Investigational New Drug Application (IND) of Fucosu was approved again, and the indication is to be expanded for the treatment of patients with relapsed/refractory multiple myeloma who have previously undergone 1-2 lines of therapy and are resistant to lenalidomide. This year, the IND for the treatment of autoimmune diseases such as refractory generalized myasthenia gravis (gMG) was also approved in China and the United States.

Regarding the future development plan of Fukesu, IASO Biotech told Times Finance, "At present, Fukesu is conducting phase III clinical exploration, and the indication is patients with relapsed/refractory multiple myeloma who have undergone 1-2 lines of previous treatment and are resistant to lenalidomide. In addition, we are actively expanding the potential of Focosu in the treatment of high-risk first-line myeloma patients. Outside of oncology, we have also invested a lot of energy in the study of the application of Focosu in the treatment of autoimmune diseases. We will continue to invest resources to advance the use of Phocosu in multiple therapeutic areas. ”

In terms of commercialization, at present, Fukesu has been included in Ningningbao, Ninghuibao, Fuhankang, Huixiabao (2024 version) and other cities Huimin Insurance. Reindeer Biotech told Times Finance that up to now, Fukesu has covered Huimin Insurance in 86 regions. Among them, taking Wuhan Huimin Insurance in 2024 as an example, Fukesu has been included in the CAR-T drug list catalog of the local Huimin Insurance "Fuhankang", with a payment ratio of 0 deductible, 70% compensation for healthy individuals, and up to 30% for non-healthy individuals, with a maximum payment of 25w.

Behind IASO Bio's exploration of CAR-T cell therapy is the rapid development of the entire cell and gene therapy industry. According to the statistics of Times Finance, as of March this year, CARsgen Pharmaceutical (02171. HK) CAR-T cell therapy Zevogene autoleucel injection (trade name: Sekaize) has been approved for marketing in China, and more than 10 products have been approved worldwide, including six related products in the U.S. market.

In the Chinese market, 5 CAR-T products have been approved for marketing, including Fosun Pharma (600196. SH； 02196.HK) The joint venture company Fosun Kite's Axileucel Injection (trade name: Yikaida), JW Therapeutics (02126. HK), Naki-cel Injection (trade name: Carteyda), Naki-cel Injection (trade name: Yuanruida) of Heyuan Biologics, and Sakaize of CARsgen.

In terms of pricing, the prices of the five domestic CAR-T products are all around one million yuan, of which the highest price is more than 1.2 million yuan/needle, and the lowest is Yuanruida of Heyuan Biotechnology, which was previously announced at 999,000 yuan/needle.

According to the Cancer Research Institute, as of June 1, 2022, there were 2,756 cell therapy pipelines under development worldwide, an increase of 39.8% from 2,031 pipelines in 2021. CAR-T dominates different types of cell therapy, with 282 new pipelines added in 2022 compared to 2021, a year-on-year increase of 24.5%.

According to data from Precedence Research, the global CAR-T cell therapy market size was $3.8 billion in 2022 and is expected to reach about $88.52 billion by 2032, with a compound annual growth rate of 29.8% from 2023 to 2032.

As far as the domestic market is concerned, data released by The Lancet Haematology shows that from 2018 to 2021, domestic CAR-T cell therapy companies raised as much as $2.37 billion. The research institute Frost & Sullivan previously predicted that from 2021 to 2025, the size of China's CAR-T therapy market (at cost price) will rise from 200 million yuan to 8 billion yuan, with a compound annual growth rate of 151.0%. With the approval of more CAR-T products, the market size is expected to reach 28.9 billion yuan in 2030.